PMA P100001S005
- Device
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE
- Applicant
- Ortho-Clinical Diagnostics
- PMA number
- P100001
- Supplement
- S005
- Product code
- LOM
- Decision date
- 2012-12-21
- Classification
- Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- CHANGE TO THE LIMITS OF AN IN-PROCESS TEST USED IN THE ASSESSMENT OF STREPTAVIDIN COATED WELLS, A COMPONENT OF THE DEVICE.
Current openFDA PMA Record#
- Device
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE
- Applicant
- Ortho-Clinical Diagnostics
- PMA number
- P100001
- Supplement
- S005
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2012-12-21
- Decision code
- OK30
- Date received
- 2012-11-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE LIMITS OF AN IN-PROCESS TEST USED IN THE ASSESSMENT OF STREPTAVIDIN COATED WELLS, A COMPONENT OF THE DEVICE.